Sun Pharma Gets U.S. FDA Nod For Generic Drug Mesalamine Extended Release Capsules

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Capsules and tablets. (Photo: Ksenia Yakovleva/Unsplash)

Sun Pharmaceutical Industries Ltd. on Thursday said it has received final approval from the U.S. health regulator for Mesalamine extended-release capsules, used to treat bowel disease, in the American market.

The company has received approval from the U.S. Food and Drug Administration for the product, a generic version of Pentasa extended release capsules (500 mg), the Mumbai-based drug major said in a statement.

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As per March 2022 IQVIA Health data, Pentasa had annualised sales of around $213 million in the U.S. market.

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